Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
estradiol, Quantity: 5.69 mg
Bayer Australia Ltd
Drug delivery system, transdermal
Excipient Ingredients: ethyl oleate; isopropyl myristate; glyceryl laurate; acrylates/acrylamide copolymer
Transdermal
4 sachets, 12 sachets, 1 sachet, 8 sachets, 2 sachets
(S4) Prescription Only Medicine
OTHER CONDITIONS: Do not remove from primary pack except for immediate use. For short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. Oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. In women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,For short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. For the prevention of post menopausal bone mineral density loss. When prescribed solely for the prevention of post menopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who, are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. Lifestyle modifications and the risk benefit profile of CLIMARA should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing (see precautions and dosage and administration sections). In women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.
Visual Identification: Oval shaped patch (approx 5.5cmx4.1cm=18.75cm2) consisting of translucent polyethylene backing& pressure sensitive acrylate adhesive/drug matrix. The patch is mounted on clear, split release liner; Container Type: Sachet; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2000-10-16
CLIMARA® CMI V1.0 1 CLIMARA® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING CLIMARA®? CLIMARA® contains the active ingredient estradiol. CLIMARA® is used for the treatment of menopausal symptoms due to estrogen deficiency during menopause or after a surgical procedure, where estrogen production is decreased. For more information, see Section 1. Why am I using CLIMARA®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CLIMARA®? Do not use if you have ever had an allergic reaction to estradiol or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use CLIMARA®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CLIMARA® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CLIMARA®? CLIMARA® patches are usually worn continuously, and replaced every 7 days. You should only wear one patch at a time, unless your doctor tells you otherwise. The best place to apply CLIMARA® patches is on your lower abdomen or buttocks. Never put CLIMARA® patches on your breasts. More instructions can be found in Section 4. How do I use CLIMARA®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CLIMARA®? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CLIMARA®. • If you become pregnant while taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not take CLIMARA® to treat any other complaints unless your doctor tells you to. • Do not give you Leggi il documento completo
CLIMARA PI V1.0, CCDS 16 1 AUSTRALIAN PRODUCT INFORMATION CLIMARA ® (ESTRADIOL) TRANSDERMAL DRUG DELIVERY SYSTEM WARNING Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens (0.625 mg) relative to placebo (see section 5.1 Pharmacodynamic properties - Clinical trials and 4.4 Special warnings and precautions for use). The WHI study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see section 5.1 Pharmacodynamic properties - Clinical trials and 4.4 Special warnings and precautions for use). The Women’s Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see section 5.1 Pharmacodynamic properties - Clinical trials and 4.4 Special warnings and precautions for use). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 NAME OF THE MEDICINE Estradiol 2 QUALITATIVE Leggi il documento completo